The following table gives a
detailed description of the type of information prompted for by the data entry
fields. Elements provided to guide the user include predefined picklist phrases, freetext
templates and context-sensitive help texts. In addition, technical elements are
provided, i.e. field and data types, explanations for use in Data Element
Dictionary (DED) and the xml schema. The conventions used are explained in part
'Introduction
and Format of OECD Harmonised Templates'.

Field number

Field description

[Field label]

Field type

Data type

Group ID

Max occ.

Detail level

Picklist code

Remarks, Picklist, Freetext
template

Help text

Explanation for use in Data Element Dictionary (DED)

XML Schema

ADMINISTRATIVE
DATA

REMARKS:

Under
this main heading, fields are subsumed for identifying the purpose of the
record (e.g., 'key study'), the type of result
(e.g., 'experimental study'), data waiving indication (if any), reliability
indication, and flags for indicating the regulatory purpose envisaged and/or
any confidentiality restrictions. This kind of data characterise
the relevance of a study summary and may therefore be displayed on top of
each template. For detailed guidance, refer to Administrative data.

SE06.01.03.0215

DATA SOURCE

[Data
source]

HEAD-1

Heading level 1

[N/A]

1

1

[N/A]

Main heading under which generic 'Data source' fields are subsumed.

SE06.01.03.0219

Reference

[Reference]

HEAD BLOCK

Block label

g313

10

1

[N/A]

Indicate the bibliographic reference of the study report or publication
the study summary is based on. Always enter the primary reference in the
first block of fields (i.e. Sort no. = 1), if there are
more than one reference to be cited. Copy this block of fields for specifying
any other references related to this record (e.g. report of a preliminary
study or other documentation). If results of a study report have been
published, indicate the full citation of that publication(s) in addition to
the reference of the original study.

Indicate the type of reference, e.g. 'Study report' or 'Publication'.
Select 'Other company data' to characterise any
unpublished information from a company other than a study report. Select
'Grey literature' for any other unpublished information or 'other:' and
specify.

For ease of sorting and searchability use
following convention: Surname, Initial (Example 1: White D, Ruehl KJ, Borman SA &
Little J. Example 2: Hartley M & Murray W (avoid unnecessary full-stops,
commas)). If no individuals are cited as authors, enter name of company or organisation or 'Anon.' as appropriate.

Note that the complete bibliographic reference may appear in this field
after migration of unstructured data from existing databases.

Name(s) of author(s) of the study report or publication.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_AUTHOR>

<i5:REFERENCE_AUTHOR>

SE06.01.03.0240

Year

[Year]

YEAR

NUMBER/4/###0

g313

1

1

[N/A]

Enter year of study report or publication. For a study report this field
should be completed to include it in any searches, regardless of whether the
complete date is given in field 'Report date'.

Year of the study report or publication.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_YEAR>

<i5:REFERENCE_YEAR>

SE06.01.03.0250

Title

[Title]

TEXT

STRING/255

g313

1

1

[N/A]

Include the title of the report. For publications, include the title of
the article of a journal or article/chapter of a book (e.g. handbook).

Title of a study report or title of published article of journal or book
(e.g. handbook).

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TITLE>

<i5:REFERENCE_TITLE>

SE06.01.03.0260

Bibliographic source

[Bibliographic
source]

TEXT

STRING/255

g313

1

1

[N/A]

Not relevant for any study report. For publications or any other
literature source (grey literature) specify the following type of
information: (i) Title of scientific journal or book (e.g. if handbook); (ii)
Volume of journal; (iii) Editor, publisher, place of publication for books or
articles in books; (iv) Pagination.

Select appropriate indication for data access. Enter 'Not applicable' if
the summary consists of information that is commonly accessible such as
guidance on safe use.

Indication for data access.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE06.01.03.0321

Data access

[no
label]

OTHERTEXT

STRING/255

[N/A]

1

1

[N/A]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE06.01.03.0330

Data protection claimed

[Data
protection claimed]

LIST-CLOSED-SUP

STRING/255

[N/A]

1

1

Z30

Picklist Values:

yes
|| yes, but willing to share || yes, but not willing to share

Indicate as appropriate. Note: 'yes' should be selected only if 'Data
submitter is data owner' or 'Data submitter has Letter of Access'. Options
'yes, but willing to share' or 'yes, but not willing to share' may be
relevant for specific regulatory programmes where
the submitter is requested to indicate whether he is willing to share studies
(e.g. with vertebrates).

In the supplementary remarks field, include an explanation as appropriate,
i.e. justification for denial of sharing the corresponding study or refer to
a document attached that provides justification (e.g. 'for justification see
attached document X')

Indication if data protection is claimed by the submitter who has to be
data owner or have letter of access.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE06.01.03.0331

Data protection claimed

[no
label]

SUP-TEXT

STRING/255

[N/A]

1

1

[N/A]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE06.01.03.0340

Cross-reference to same study

[Cross-reference
to same study]

TEXTAREA

STRING/2000

[N/A]

1

1

[N/A]

A cross-reference can be included to indicate that the same study is
recorded in another record. Indicate the respective chapter and record ID and
enter relevant explanatory text. This may be useful if specific endpoints of
a given study are described in another chapter (e.g. results on reproduction
toxicity in case of a combined repeated dose / reproduction toxicity study)
or if more than one experiment is described by the same study report, but
included in separate records.

Check with the relevant guidance document whether all the methodology
details must be repeated or whether a cross-reference to the same study in
another chapter may suffice.

Note that any such cross-reference may become useless if a record is
either printed or exchanged on its own.

Indication that the same study is described in another study summary /
chapter of the data set.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:CROSSREF_SAMESTUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.01.03.0345

MATERIALS AND METHODS

[Materials
and methods]

HEAD-1

Heading level 1

[N/A]

1

1

[N/A]

Main heading under which generic 'Materials and methods' fields are subsumed.

SE06.01.03.0349

Test guideline

[Test
guideline]

HEAD BLOCK

Block label

g314

5

1

[N/A]

Indicate according to which test guideline the study was conducted. If no
test guideline was explicitly followed, but the methodology used is
equivalent or similar to a specific guideline, you can indicate so in the
'Qualifier' subfield preceding the field 'Guideline'.

Copy this block of fields for specifying more than one guideline (e.g. US
EPA in addition to OECD guideline).

Heading of field block 'Guideline'

SE06.01.03.0350

Qualifier

[Qualifier]

LIST-CLOSED

STRING/255

g314

1

1

Z06

Picklist Values:

according
to || equivalent or similar to || no guideline followed || no guideline
available || no guideline required

Select appropriate qualifier, i.e.

- 'according to' (if a given test guideline was followed);

- 'equivalent or similar to' (if no test guideline was explicitly
followed, but the methodology is equivalent or similar to a specific
guideline);

- 'no guideline followed' (if none of above qualifiers apply. If so, fill
in field 'Principles of method if other than guideline');

- 'no guideline available' (if so, fill in field 'Principles of method if
other than guideline').

- 'no guideline required' (if so, fill in field 'Principles of method if
other than guideline').

An indicator signifying how strict the guideline given in the subsequent
field 'Guideline' was followed or whether no guideline was used or
available/required.

Select the applicable test guideline, e.g. 'OECD Guideline xxx'. If the
test guideline used is not listed, choose 'other guideline:' and specify the
test guideline in the related text field.

In this text field, you can also enter any remarks as applicable,
particularly:

- To include any other title of the test guideline draft used, a subtitle,
another version or update number and the year of update (For instance,
different titles and/or numbers may exist for a given EU test guideline.);

- To indicate if a the study was performed prior to the adoption of the
test guideline specified;

- To indicate if the methodology used was based on an extension of the
test guideline specified.

The name of the guideline followed in performing the study or to which the
method used can be compared. Also indication if no guideline was used, available
or required. In supplementary remarks field indication of guideline version
or title if deviating from the picklist value, or
of additional test guidelines cited.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE>

SE06.01.03.0361

Guideline

[no
label]

SUP-TEXT

STRING/255

g314

1

1

[N/A]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE_TXT>

SE06.01.03.0370

Deviations from guideline

[Deviations]

LIST-CLOSED-SUP

STRING/255

g314

1

1

Z08

Picklist Values:

yes
|| no || no data || not applicable

For robust study summaries or as requested by the regulatory programme,
indicate if there are any deviations from the test guideline specified. If
'yes' is selected, only briefly state relevant deviations in the supplementary
remarks field (e.g. 'other species used'); details should be described in the
respective fields of the section MATERIALS AND METHODS.

Indication that a study contains deviations from the standard test
protocol.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION>

SE06.01.03.0371

Deviations from guideline

[no
label]

SUP-TEXT

STRING/255

g314

1

1

[N/A]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION_TXT>

SE06.01.03.0380

Principles of method if other than guideline

[Principles
of method if other than guideline]

TEXTAREA

STRING/32768

[N/A]

1

1

[N/A]

If no guideline was followed, include a description of the principles of
the test protocol or estimated method used in the study. Details should be
entered in appropriate distinct fields of section MATERIALS AND METHODS if
available. Also provide a justification for using this method if appropriate.

If an estimation method was used (to be indicated in field 'Study result
type') state the equation(s) and/or computer software or other methods
applied to calculate the value(s).

Description of the test protocol or estimated method used in the study, if
other than a guideline, and justification for using this method if
appropriate.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:METHOD_NOGUIDELINE>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE06.01.03.0390

GLP compliance

[GLP
compliance]

LIST-CLOSED-SUP

STRING/255

[N/A]

1

1

Z40

Picklist Values:

yes
(incl. certificate) || yes || no || no data

Indicate whether the study was conducted following Good Laboratory
Practice or not. Select 'yes (incl. certificate)' if a GLP certificate of a
test facility is available. Select 'yes' if a GLP compliance statement is
available, but no information on a GLP certificate. You can give an
explanation in the supplementary remarks field, e.g. for explaining why GLP
was not complied with or for specifying which (national) GLP was followed.

Indication whether a GLP certificate or compliance statement is available.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE06.01.03.0391

GLP compliance

[no
label]

SUP-TEXT

STRING/255

[N/A]

1

1

[N/A]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE06.01.03.0395

Test materials

[Test
materials]

HEAD-2

Heading level 2

[N/A]

1

1

[N/A]

Subheading of section 'Test materials'

SE06.01.03.0400

Test material equivalent to submission substance identity

[Identity
of test material same as for substance defined in section 1 (if not
read-across)]

LIST-CLOSED

STRING/255

[N/A]

1

1

Z38

Picklist Values:

yes
|| no

Select 'yes' or 'no' from the drop-down list for indicating that the
identity of the test material is the same or is not the same, respectively,
as for substance defined in section 1 (General information). In addition, the
identity of the test material should be specified in the subsequent block of
fields 'Test material identity'.

NOTE: You cannot update this field, if a completed record is copied to
another submission substance as reference. Therefore, in case of read-across
the indication of 'yes' is not relevant.

Indicator showing whether the test material used is equivalent to the
submission substance identity.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:TESTMAT_INDICATOR>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE06.01.03.0409

Test material identity

[Test
material identity]

HEAD BLOCK

Block label

g315

10

1

[N/A]

Indicate the identity of the test material for one or more appropriate
identifiers, e.g. CAS number, CAS name, IUPAC name. Copy this block of fields
as appropriate.

NOTE: In order to avoid confusion on the test material identity it is
highly recommended to enter at least one substance identifier, regardless of
what has been entered in field 'Identity of test material same as for
substance defined in section 1 (if not read-across)'.

Heading of field block 'Test material identity'

SE06.01.03.0410

Identifier

[Identifier]

LIST-OPEN

STRING/255

g315

1

1

Z39

Picklist Values:

CAS
name || CAS number || Common name || EC name || EC number || IUPAC name ||
TSCA name || other:

Select an appropriate identifier from drop-down list, e.g. 'CAS number'.
Use 'Other:' and specify, if identity according to a standard identifier is
not known or if an additional chemical name or number is provided.

Indicator specifying the type of chemical identifier, e.g. CAS name.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER>

SE06.01.03.0411

Identifier

[no
label]

OTHERTEXT

STRING/255

g315

1

1

[N/A]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER_TXT>

SE06.01.03.0420

Identity

[Identity]

TEXT

STRING/2000

g315

1

1

[N/A]

Select the corresponding substance identity from drop-down list or enter
manually if the identity is not available from the list or if no list is
provided for the type of identifier selected.

Identity of the chemical substance used in the study or referred to in the
record.

Select the test material form from the drop-down list. If the form of the
test chemical is not available in the list, select 'other:' and specify in
the adjacent field. If the test material form is unknown, select 'no data'.

Form of the substance, i.e. powder, crystalline, compact, viscous, etc.

Use freetext template and delete/add elements as
appropriate. Enter any details that could be relevant for evaluating this
study summary or that are requested by the respective regulatory programme.
Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or
EU REACH) thereof.

Note that any information that can be claimed confidential should be
included in the subsequent field 'Confidential details on test material'.

Explanations:

- Name of test material (as cited in study report): only if different from
any other identifiers provided in the preceding fields.

- Molecular formula (if other than submission substance): specify

- Molecular weight (if other than submission substance): specify

- Smiles notation (if other than submission substance): provide if
available

- InChl (if other than submission substance):
provide if available

- Structural formula attached as image file (if other than submission
substance): see Fig.: only if different from submission substance. Indicate
Fig. no. if a file is attached in field 'Attached document', e.g. state 'see
Fig. 1'.

Enter any confidential information on the test material in this separate
field. Use freetext template and delete/add
elements as appropriate. Enter any details that could be relevant for
evaluating this study summary or that are requested by the respective
regulatory programme. Consult the programme-specific guidance (e.g. OECD
HPVC, Pesticides NAFTA or EU REACH) thereof.

Explanations:

- Analytical purity: specify in %

- Impurities (identity and concentrations): specify

- Composition of the test material, percentage of components: specify if
applicable

- Purity test date: provide if available

- Lot/batch No.: : provide if available

- Expiration date of the lot/batch: : provide if available

- Isomers composition: specify if applicable

Confidential details on the actual test material.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:TESTMAT_CONFIDENTIAL_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.01.03.0450

Details on properties of test surrogate or analogue material

[Details
on properties of test surrogate or analogue material]

TEXT-TEMPL

STRING/32768

[N/A]

1

2

[N/A]

Freetext Templates:

PHYSICO-CHEMICAL PROPERTIES

- Melting point:

- Boiling point:

- Vapour pressure:

- Water solubility (under test conditions):

- Henry's law constant:

- log Pow:

- pKa:

- Stability in water:

- Stability in light:

- pH dependence on stability:

OTHER PROPERTIES (if relevant for this endpoint)

- Results of test for ready biodegradability:

- Other:

ONLY if another substance, i.e. analogue or surrogate (e.g.
degradation/transformation product) was used as test material, enter any
relevant details on the properties of this substance that may possibly affect
the test performance, particularly physico-chemical
properties.

Use freetext template and delete/add elements as
appropriate.

Note that the physico-chemical properties of the
substance for which the submission is made should be recorded in the
corresponding templates and therefore need not be repeated here.
Nevertheless, the possible influence of any physico-chemical
properties should be indicated / discussed in appropriate fields,
particularly in fields 'Details on test conditions' and 'Details on results'.
This holds also true if any property of the substance is different in the
test medium as compared to the data recorded in the section on physico-chemical properties, e.g. lower water solubility.

Details on properties of test material, particuarlyphysico-chemical properties. Relevant if an
analogue or surrogate was used.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:PROPERTIES_TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.01.03.0460

Analytical monitoring

[Analytical
monitoring]

LIST-CLOSED

STRING/255

[N/A]

1

1

Z36

Picklist Values:

yes
|| no || no data || not required

Indicate whether test substance was monitored in the test solutions.

For robust study summaries or as requested by the regulatory programme,
provide further details on sampling and analytical methods in the
corresponding freetext fields.

Indicator that instrumental analyses were applied to detect the precise
amount of chemical exposed to the organisms.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:ANALYT_MONIT>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE06.01.03.0470

Details on sampling

[Details
on sampling]

TEXT-TEMPL

STRING/32768

[N/A]

1

2

[N/A]

Freetext Templates:

- Concentrations:

- Sampling method:

- Sample storage conditions before analysis:

If the amount of test material exposed to the organisms was monitored,
enter details on sampling. Use freetext template as
appropriate and delete/add elements as appropriate.

Details on sampling.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:SAMPLING_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.01.03.0480

Details on analytical methods

[Details
on analytical methods]

TEXT-TEMPL

STRING/32768

[N/A]

1

2

[N/A]

Freetext Templates:

DETAILS ON PRETREATMENT

- Centrifugation:

- Filtration:

- Digestion (acid used, method: e.g. micro-oven):

- Extraction (solvent used, method: e.g. liquid-liquid, SPE):

- Clean up method: e.g. chemical used for chemistry method (Cu, Hg, ...)
or phase and solvent used for SPE method:

Use freetext template and delete/add elements as
appropriate. Enter any details that could be relevant for evaluating this
study summary or that are requested by the respective regulatory programme.
Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or
EU REACH) thereof.

Use freetext template and delete/add elements as
appropriate. Enter any details that could be relevant for evaluating this
study summary or that are requested by the respective regulatory programme.
Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or
EU REACH) thereof.

Details on test organisms and acclimation.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:ORGANISM_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.01.03.0525

Study design

[Study
design]

HEAD-2

Heading level 2

[N/A]

1

1

[N/A]

Subheading of section 'Study design'

SE06.01.03.0530

Test type

[Test
type]

LIST-OPEN

STRING/255

[N/A]

1

1

E01

Picklist Values:

static
|| semi-static || flow-through || other: || no data

Select appropriate test type.

Indicator showing whether medium was supplied in a static, semi-static or
flow-through way.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:TESTTYPE_AQUATOX>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE06.01.03.0531

Test type

[no
label]

OTHERTEXT

STRING/255

[N/A]

1

1

[N/A]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:TESTTYPE_AQUATOX>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE06.01.03.0540

Water media type

[Water
media type]

LIST-CLOSED

STRING/255

[N/A]

1

1

E102

Picklist Values:

freshwater
|| saltwater || brackish water || no data

Indicate whether organisms were tested in fresh-/salt- or
brackish/estuarine water.

For freshwater tests, indicate water hardness as mg/L calcium carbonate
equivalent values measured in the treatment and control solutions during
test. Include range, mean, standard deviation and unit. Alternatively refer
to table (e.g. 'see table no. 2') if the test conditions are presented in
tabular form in the rich text editor field.

The concentration of calcium and magnesium ions in water, measured as mg/L
calcium carbonate equivalent.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:HARDNESS>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.01.03.0610

Test temperature

[Test
temperature]

TEXTAREA

STRING/2000

[N/A]

1

2

[N/A]

Indicate test temperature values measured in the treatment and control
solutions during test. Include range, mean, standard deviation and unit. As
appropriate state the location (e.g. water bath, test chambers) and type of
measurement (e.g. continuous monitoring). Alternatively refer to table (e.g.
'see table no. 2') if the test conditions are presented in tabular form in
the rich text editor field.

The temperature used in the experimental determination of the test value.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:TEST_TEMP>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.01.03.0620

pH

[pH]

TEXTAREA

STRING/2000

[N/A]

1

2

[N/A]

Indicate pH values measured in the treatment and control solutions during
test. Include range, mean, standard deviation and unit. Alternatively refer
to table (e.g. 'see table no. 2') if the test conditions are presented in
tabular form in the rich text editor field.

The pH value applicable to the measured test value or mean or range.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:PH>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.01.03.0630

Dissolved oxygen

[Dissolved
oxygen]

TEXTAREA

STRING/2000

[N/A]

1

2

[N/A]

Indicate dissolved oxygen values measured in the treatment and control
solutions during test. Include range, mean, standard deviation and unit.
Alternatively refer to table (e.g. 'see table no. 2' )
if the test conditions are presented in tabular form in the rich text editor
field.

The amount of soluble oxygen in water including mean or range.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:DISS_OXYGEN>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.01.03.0640

Salinity

[Salinity]

TEXTAREA

STRING/2000

[N/A]

1

2

[N/A]

For marine studies, indicate salinity values measured in the treatment and
control solutions during test. Include range, mean, standard deviation and
unit. Alternatively refer to table (e.g. 'see table no. 2'
) if the test conditions are presented in tabular form in the rich
text editor field.

The salinity used in the experimental determination of the test value.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:SALINITY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.01.03.0650

Nominal and measured concentrations

[Nominal
and measured concentrations]

TEXTAREA

STRING/2000

[N/A]

1

2

[N/A]

REMARKS:

Available predefined table(s) are displayed
below, after this template. See also List of Predefined Tables in Annex 2.

List nominal and, if available, measured test concentrations (with unit).
As appropriate tabulate nominal vs. measured concentrations in the rich text
field 'Any other information on results incl. tables'. Upload predefined
table(s) if any or adapt table(s) from study report. Use table numbers in the
sequence in which you refer to them in the Remarks text (e.g. '... see Table
1').

Use alternative predefined tables if data for both the technical end
product and the active ingredient are to be recorded.

- Justification for using less concentrations than requested by guideline:

- Range finding study

- Test concentrations:

- Results used to determine the conditions for the definitive study:

Use freetext template and delete/add elements as
appropriate. Enter any details that could be relevant for evaluating this
study summary or that are requested by the respective regulatory programme.
Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or
EU REACH) thereof.

Further details on test conditions.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:TESTCONDIT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.01.03.0670

Reference substance (positive control)

[Reference
substance (positive control)]

LIST-CLOSED-SUP

STRING/255

[N/A]

1

2

Z36

Picklist Values:

yes
|| no || no data || not required

Indicate if a positive control was tested, i.e. a reference substance with
known toxicity. If yes, include the identity of the substance(s) and the
concentrations in the supplementary remarks field.

In this field, you can enter any information on materials and methods, for
which no distinct field is available, or transfer free text from other
databases. You can also open a rich text editor and create formatted text and
tables or insert and edit any excerpt from a word processing or spreadsheet
document, provided it was converted to the HTML format.

Note: One rich text editor field each is provided for the MATERIALS AND
METHODS and RESULTS section. In addition the fields 'Overall remarks' and
'Executive summary' allow rich text entry.

Rich text editor field for creating formatted text and tables or inserting
and editing any excerpt from a word processing or spreadsheet document,
provided it was converted to the HTML format.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:REM_ME_TC>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE06.01.03.0685

RESULTS AND DISCUSSION

[Results
and discussions]

HEAD-1

Heading level 1

[N/A]

1

1

[N/A]

Main heading under which generic 'Results and discussion' fields are subsumed.

SE06.01.03.0689

Effect concentrations

[Effect
concentrations]

HEAD BLOCK

Block label

g316

20

1

[N/A]

Report the LC50 or other effect levels. Copy this field block for entering
more than one effect level if necessary.

Heading of field block 'Effect concentrations'

SE06.01.03.0690

Exposure duration

[Duration]

NUM

NUMBER/20/########0.#########

g316

1

1

[N/A]

Enter numeric value.

Numeric value of exposure duration to which the effect concentration
refers.

Effect concentration: Upper qualifier field providing a list with
following operators: <, <=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:EFFCONC>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPQUALIFIER>

SE06.01.03.0750

Effect concentration

[no
label]

NUM

NUMBER/20/########0.#########

g316

1

1

[N/A]

Effect concentration: Upper numeric field for entering a numeric value
only if either a lower value is already entered to specify a numeric range or
if the numeric value is preceded by either operator '<' or '<='.

Indicate whether the concentration is based on the test material (test matl), active ingredient (act. ingr.),
element, dissolved (if inorganic non-metal), labile/free (if metal) or other
(specify). Further information can be given in the supplementary remarks
field.

Select 'no data' if effect concentration type is not known.

Indication of whether the concentration is based on the test material,
active ingredient, free metal etc.

Briefly summarize relevant observations and any dose response
relationship. Use freetext template and delete/add
elements as appropriate. As an option you may include an excerpt from the
study report.

Include tables with raw data and refer to respective table no. (use predefined table(s) if any or adapt table(s) from
study report). As appropriate attach figure with growth curves.

Additional information on results

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:RESULTS_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.01.03.0820

Results with reference substance (positive control)

[Results
with reference substance]

TEXT-TEMPL

STRING/32768

[N/A]

1

2

[N/A]

Freetext Templates:

- Results with reference substance valid?

- Mortality:

- EC50/LC50:

- Other:

If reference substance(s) was/were tested, indicate whether the results
with it/them are valid and provide mortality, EC50/LC50 data and other
relevant information.

Use freetext template and delete/add elements as
appropriate.

Indication whether the results with the reference substance(s) are valid.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:RS_REF_SUBSTANCE>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.01.03.0830

Reported statistics and error estimates

[Reported
statistics and error estimates]

TEXTAREA

STRING/2000

[N/A]

1

2

[N/A]

Indicate the parameters analyzed, the statistical method used and the
statistical test performed. If probit analysis was
used, indicate the intercept and probit slope. As
appropriate state any relevant error estimates associated with the
determination of concentration-response relationship.

Indication of statistical data and error estimates associated with the
determination of the concentration-response relationship.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:STATISTICS>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE06.01.03.0840

Any other information on results incl. tables

[Any
other information on results incl. tables]

RICHTEXT

STRING/256000

[N/A]

1

1

[N/A]

In this field, you can enter any other remarks on results. You can also
open a rich text editor and create formatted text and tables or insert and
edit any excerpt from a word processing or spreadsheet document, provided it
was converted to the HTML format.

Note: Both the 'Materials and methods' section and 'Results' section. In
addition the fields 'Overall remarks' and 'Executive summary' allow rich text
entry.

Rich text editor field for creating formatted text and tables or inserting
and editing any excerpt from a word processing or spreadsheet document,
provided it was converted to the HTML format.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:REM_RS>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE06.01.03.0845

OVERALL REMARKS, ATTACHMENTS

[Overall
remarks, attachments]

HEAD-1

Heading level 1

[N/A]

1

2

[N/A]

Briefly summarise relevant observations and any
dose response relationship. Use freetext template
and delete/add elements as appropriate. As an option you may include an
excerpt from the study report.

Include table(s) with raw data in the rich text field 'Any other
information on results incl. tables'. Upload predefined table(s) if any or
adapt table(s) from study report. Use table numbers in the sequence in which
you refer to them in the text (e.g. '... see Table 1').

As appropriate also attach a figure with growth curves in field 'Attached
background material'.

Main heading under which 'Overall remarks, attachments' fields are subsumed.

SE06.01.03.0850

Remarks on results including tables and figures

[Remarks
on results including tables and figures]

RICHTEXT

STRING/256000

[N/A]

1

1

[N/A]

In this field, you can enter any overall remarks or transfer free text
from other databases. You can also open a rich text editor and create
formatted text and tables or insert and edit any excerpt from a word
processing or spreadsheet document, provided it was converted to the HTML
format.

Note: One rich text editor field each is provided for the MATERIALS AND
METHODS and RESULTS section. In addition the fields 'Overall remarks' and
'Executive summary' allow rich text entry.

Rich text editor field for creating formatted text and tables or inserting
and editing any excerpt from a word processing or spreadsheet document,
provided it was converted to the HTML format.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:REM_ANYOTHER>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE06.01.03.0859

Attached background material

[Attached
background material]

HEAD BLOCK

Block label

g317

10

1

[N/A]

Attach any background document that cannot be inserted in any rich text
editor field, particularly image files (e.g. an image of a structural
formula).

Copy this block of fields for attaching more than one file.

Heading of field block 'Attached document'.

SE06.01.03.0860

Attached document

[Attached
document]

ATTACHMENT

STRING/32768

g317

1

1

[N/A]

Upload file by clicking the upload icon. As appropriate, enter any
additional information, e.g. language. The file name is displayed after
uploading the document.

File name of document uploaded, i.e. attached. No restriction as to file
type.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:AD>

<i5:set>

<i5:DOC>

<i5:DOC>

SE06.01.03.0870

Remarks

[Remarks]

TEXT

STRING/255

g317

1

1

[N/A]

As appropriate, include remarks, e.g. a short description of the content
of the attached document if the file name is not self-explanatory.

Remarks on attached document.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:AD>

<i5:set>

<i5:REM>

<i5:REM>

SE06.01.03.0879

Attached full study report

[Attached
full study report]

HEAD BLOCK

Block label

g318

10

1

[N/A]

If required, an electronic copy of the full study report can be attached
as WORD, pdf or other document type, which will not
be integrated in any report, but must be handled as separate files.

Note: In the export administration you can indicate whether the attached
files should be included in the data export or not.

Attached full study report

SE06.01.03.0880

Attached full study report

[Attached
full study report]

ATTACHMENT

STRING/32768

g318

1

1

[N/A]

Upload file by clicking the upload icon. As appropriate, enter any
additional information, e.g. language. The file name is displayed after
uploading the document.

Attached full study report

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:AD_STUDYREPORT>

<i5:set>

<i5:ATTACHMENT_BELOW>

<i5:ATTACHMENT_BELOW>

SE06.01.03.0882

Illustration (picture/graph)

[Illustration
(picture/graph)]

PICTURE

STRING/32768

[N/A]

1

1

[N/A]

Upload file by clicking the upload icon. As appropriate, enter any
additional information, e.g. language. The file name is displayed after
uploading the document.

Illustration (picture/graph)

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:PG_ILLUSTRATION>

<i5:set>

<i5:PIC_BELOW>

<i5:PIC_BELOW>

SE06.01.03.0885

APPLICANT'S SUMMARY AND CONCLUSION

[Applicant's
summary and conclusion]

HEAD-1

Heading level 1

[N/A]

1

1

[N/A]

Main heading under which generic 'Applicant's summary and conclusion'
fields are subsumed.

SE06.01.03.0890

Validity criteria fulfilled

[Validity
criteria fulfilled]

LIST-CLOSED-SUP

STRING/255

[N/A]

1

1

F102

Picklist Values:

yes
|| no || no data || not applicable

Indicate whether validity criteria given by test guideline have been
fulfilled or not. Use supplementary remarks field for indicating the criteria
and entering remarks. Clearly indicate if the criteria used are not consistent
with those given by the test guideline. If so, give justification in field
'Rationale for reliability incl. deficiencies' as to why this study summary
is considered reliable.

Indication of validity criteria and whether they have been fulfilled or
not.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:VALIDITY_CRIT_SUBM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE06.01.03.0891

Validity criteria fulfilled

[no
label]

SUP-TEXT

STRING/255

[N/A]

1

1

[N/A]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:VALIDITY_CRIT_SUBM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE06.01.03.0900

Conclusions

[Conclusions]

TEXTAREA

STRING/32768

[N/A]

1

1

[N/A]

Enter any conclusions if applicable.

Any conclusions either as adapted from the study report / publication or
indicated by the submitter.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:APPL_CL>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE06.01.03.0910

Executive summary

[Executive
summary]

RICHTEXT

STRING/256000

[N/A]

1

1

[N/A]

REMARKS:

Available predefined executive summary is shown below, at the end of this
template. See also List of Predefined Executive Summaries in Annex 3.

If required by the respective national/regional programme, briefly summarise the relevant aspects of the study including the
conclusions reached. If a specific format is prescribed, upload the
respective freetext template if available from the
drop-down list or copy it from the corresponding document.

Executive summary in which the relevant aspects of the study including the
conclusions reached are briefly summarised.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_DAPHNIATOX>

<i5:APPL_EXEC_SUM>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE06.01.03.0920

Cross-reference to other study

[Cross-reference
to other study]

TEXTAREA

STRING/2000

[N/A]

1

1

[N/A]

A Cross-reference to other study or other studies can be included which
are considered relevant in the interpretation of the test results, e.g. for
supporting the conclusion that an effect observed was not substance-related.
Indicate the respective chapter(s) and record ID(s) and enter relevant
explanatory text.

Such cross-references may be useful if it is considered relevant to
discuss other results at the summary level of a single study. It should be
noted that the overall appraisal of results from different studies is
normally done in the hazard or risk assessment.

Note that any such cross-reference may become useless if a record is
either printed or exchanged on its own.

A cross-reference to another study or other studies including explanatory
text on why other results are relevant in the interpretation of the results
of a given study, e.g. for supporting any conclusions.